Rook Quality Systems (@RookQuality) header
Rook Quality Systems (@RookQuality) profile picture

Rook Quality Systems

@RookQuality

Medical Device Quality Consulting

 Atlanta, GA
rookqualitysystems.com
Joined June 2015
  • Tweets438
  • Following410
  • Followers143
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Sneak peek at our virtual health white paper. Sahee and Shawna have been working hard to share our thoughts on what the future of predictive health analytics looks like. We can’t wait to share the final paper with you! #ai #digitalhealth
Image from Tulsa Innovation Labs (@tulsainnovation)
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Ellume (@EllumeHealth) profile picture
Ellume@EllumeHealth15 Dec 2020
BREAKING: Ellume’s over-the-counter, at-home, 15-minute #COVID19 antigen test receives @US_FDA Emergency Use Authorization. The first OTC fully at-home #rapidtest. No prescription required. globenewswire.com/news-relea…
Image from Ellume (@EllumeHealth)
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FDA Medical Devices (@FDADevices) profile picture
FDA Medical Devices
@FDADevices23 Nov 2020
The @US_FDA released three videos highlighting patients’ experiences in partnering with the FDA and how patient input enhances the agency’s ability to evaluate medical devices and monitor their safety. Check out the videos.
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FDA Medical Devices (@FDADevices) profile picture
FDA Medical Devices
@FDADevices16 Nov 2020
Today, the @US_FDA issued the draft guidance, Electromagnetic Compatibility (EMC) of Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff.
Image from FDA Medical Devices (@FDADevices)
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Kinetix Fund (@KinetixFund) profile picture
Kinetix Fund@KinetixFund14 Oct 2020
Starting soon at 11:30am TODAY, 10/14!
Kinetix Fund (@KinetixFund) profile pictureKinetix Fund@KinetixFund5 Oct 2020
Want to learn networking and team-building tips for your life science #startup? Join our October 14th #Bench2MarketTalk hosted by @kirklbarnes. Free registration at b2mbuildingstartupteam.event…. @Georgia_CTSA @ibbgatech
Image from Kinetix Fund (@KinetixFund)
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Shawna Khouri (@HeyShawnaK) profile picture
Shawna Khouri@HeyShawnaK7 Oct 2020
"We may one day look back on this moment and say, 'That’s when the digital health transformation became real.'" #virtualhealth #digitalhealth @tulsainnovation statnews.com/2020/10/07/digi…
To maintain trust and respectability, digital health companies must commit to the highest standards

To maintain trust and respectability, digital health companies must commit to the highest standards

The digital health industry has been given a gift: the resources to solve the problems of health care in new ways. It's a huge opportunity and a huge responsibility. Now, in these early days, is the...

statnews.com
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NIH (@NIH) profile picture
NIH
@NIH6 Oct 2020
#NIH & @BARDA award $98.35M for scale-up & manufacturing of 6 additional #COVID19 testing technologies, the 3rd set of technologies from #RADx. Novel approaches include smart-device integration, mobile-lab processing for virus hot spots, & more: bit.ly/33yRD6s
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FDA Medical Devices (@FDADevices) profile picture
FDA Medical Devices
@FDADevices6 Oct 2020
The @US_FDA is seeking volunteers to participate in the Electronic Delivery of Premarket Submissions Pilot. This Pilot program provides a voluntary alternate method for a premarket medical device submission to CDRH during the #COVID19 public health emergency.
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Grace Powers (@gracepowers) profile picture
Grace Powers@gracepowers1 Oct 2020
“A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response” buff.ly/36lPb5c
Image from Grace Powers (@gracepowers)
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FDA Medical Devices (@FDADevices) profile picture
FDA Medical Devices
@FDADevices22 Sep 2020
Today, the @US_FDA launched the Digital Health Center of Excellence (DHCoE.) The DHCoE seeks to empower digital health stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation.
Image from FDA Medical Devices (@FDADevices)
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FDA Medical Devices (@FDADevices) profile picture
FDA Medical Devices
@FDADevices11 Sep 2020
Today @US_FDA provided market authorization for another ECG mobile app to be used OTC with a consumer wearable device--adding Fitbit to the list of manufacturers--Apple & Samsung--who provide this #DigitalHealth technology to help consumers be more engaged in their health.
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Paul Grand (@lifesciencevc) profile picture
Paul Grand@lifesciencevc31 Aug 2020
This is a HUGE win for medical devices with FDA breakthrough designation! massdevice.com/cms-agrees-to…

CMS agrees to cover 'breakthrough' medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning. Once the Medicare Coverage of Innovative Technology...

massdevice.com
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Grace Powers (@gracepowers) profile picture
Grace Powers@gracepowers31 Aug 2020
“LAWFLASH HHS LIMITS FDA OVERSIGHT OF LDTS WITHOUT FORMAL RULEMAKING, INCLUDING DURING COVID-19 PANDEMIC” buff.ly/31Fixc8
Image from Grace Powers (@gracepowers)
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Eric Topol (@EricTopol) profile picture
Eric Topol
@EricTopol27 Aug 2020
A + feature in the new $5 antigen test "uses lateral flow technology similar to a home pregnancy test and can be linked to a mobile-phone app that gives an all-clear code... test negative at work or school" Needs to be incorporated in home tests in future wsj.com/articles/abbotts-5-c…
Image from Eric Topol (@EricTopol)
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Kinetix Fund (@KinetixFund) profile picture
Kinetix Fund@KinetixFund21 Aug 2020
Announcing the 5 faculty-lead #innovations selected to participate in the newest cohort of Biolocity Launch! We look forward to supporting these patient-impacting technologies through their #commercialization milestones. sites.gatech.edu/biolocity/2…
Image from Kinetix Fund (@KinetixFund)
Image from Kinetix Fund (@KinetixFund)
Image from Kinetix Fund (@KinetixFund)
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Excited to announce that @US_FDA has granted an Emergency Use Authorization for #LumiraDx antigen test. #LumiraDx is a novel, flexible, highly scalable & low cost rapid point-of-care test that'll significantly contribute to scaling up & expanding testing platforms for #COVID19
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U.S. FDA (@FDA) profile picture
U.S. FDA
@FDA15 Aug 2020
Today, we issued an emergency use authorization to @Yale for its SalivaDirect #COVID19 diagnostic test, which uses a new method of processing saliva samples. This is the 5th test FDA has authorized using saliva as a sample for testing. fda.gov/news-events/press-an…
Image from U.S. FDA (@FDA)
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To expand Covid testing access, in addition to easier collection like using saliva; we also need fast, accurate, cheap lateral flow tests (strips) which are popular in other countries, but seldom used in U.S. because of a bias toward lab testing. We must get testing to consumers.
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Andy Slavitt (@ASlavitt) profile picture
Andy Slavitt
@ASlavitt15 Aug 2020
BREAKING: Great news. SalivaDirect received approval this morning from the @US_FDA. This could be one the first major game changers in fighting the pandemic. Rarely am I this enthusiastic. Here’s why. Follow if interested.
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Greenlight Guru (@greenlightguru) profile picture
Greenlight Guru@greenlightguru12 Aug 2020
Looking to learn the best, safest, and fastest ways to get your medical device to market? AcKnowledge Regulatory Strategies’ Reg AF Conference is coming to your desktop August 17-19th! We're a proud sponsor of the virtual event. Get your ticket today! bit.ly/2DGRVOq
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